What the plan must contain
Under SanPiN 3.3686-21 every organisation that transports, stores or uses immunobiological medicines approves a plan for fire, natural disasters, power cuts and refrigeration equipment failure. The plan covers layouts of main and backup equipment, switching to backup power, the number of refrigerators and insulated containers needed, emergency teams and duties, the notification procedure, transport and contacts. Drills are held at least once a year.
| Section | Where the data come from |
|---|---|
| Hold time without power | a power-off test during refrigerator or cold room mapping |
| Backup equipment | a backup refrigerator, insulated containers, a stock of frozen and conditioned cold packs |
| Notification | monitoring system alarms to the emergency team's phones — day and night |
| After the emergency | assessing the goods and the record — the “Temperature out of range” wizard |
Cold packs. Cold packs taken straight from a −20 °C freezer and placed against vaccines can freeze them. For products that must not freeze, use conditioned water packs or packs with a +2…+8 °C working temperature.
Frequently asked questions
Is an emergency plan mandatory for a pharmacy?
For organisations storing vaccines — yes, under SanPiN 3.3686-21. For other medicines there is no direct obligation in this form, but any storage SOP needs an emergency procedure.
How do I find out how long a refrigerator holds its temperature without power?
With a power-off test during mapping: the unit is switched off and the time until the first point exceeds +8 °C is recorded. This figure sets the timings in the plan.
How often should drills be held?
For vaccines — at least once a year under SanPiN 3.3686-21. The plan is reviewed after drills and after every emergency.